Seattle Genetics, Inc. (Nasdaq: SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502) today announced updated overall survival data from two ADCETRIS (brentuximab vedotin) pivotal Phase 2 clinical trials in relapsed/refractory Hodgkin lymphoma (R/R HL) and relapsed/refractory systemic anaplastic large cell lymphoma (R/R sALCL) were presented at the 55 th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans, LA, December 7-10, 2013. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. Median overall survival (OS) of 40.5 months was reported in R/R HL, and was not yet reached in R/R sALCL.
“The updated data from the pivotal ADCETRIS clinical trials demonstrate extended survival among this heavily pretreated patient population. Median overall survival in the relapsed/refractory Hodgkin lymphoma trial was 3.4 years, which includes 18 patients who remained in remission and were still being followed. In relapsed/refractory systemic ALCL, median overall survival had not yet been reached and the estimated three-year survival rate was 63 percent,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “These data strengthen the already demonstrated patient benefit associated with ADCETRIS in relapsed Hodgkin lymphoma and systemic ALCL disease settings and further support our three ongoing Phase 3 clinical trials in earlier lines of therapy: AETHERA in high risk post-transplant patients with Hodgkin lymphoma, ECHELON-1 in frontline Hodgkin lymphoma and ECHELON-2 in frontline mature T-cell lymphoma.”
“In this heavily pre-treated HL and sALCL patient population, exceeding three year median survival with single-agent ADCETRIS is substantial,” said Michael Vasconcelles, M.D., Senior Vice President, Head, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company. “We continue to work with regulatory agencies in our territories to expand the availability of ADCETRIS and plan to seek the inclusion of these important survival updates into our label.”